Phase 2
Completed N=49
Effects of a Range of Naltrexone Doses in Combination With Smoked Marijuana
Marijuana Use
Source: ClinicalTrials.gov NCT00403117 ↗
Enrolled (actual)
49
Serious AEs
0.0%
Results posted
Dec 2017
Primary outcomePrimary: Change in Mean Subjective Mood Scores as a Function of Marijuana Strength and Naltrexone Dose. — 8.0; 25.0; 6.7; 34.0 units on a scale
Summary
The purpose of this study is to determine if the subjective effects of marijuana will be decreased by low-doses ( 50 mg) of naltrexone.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Mean Subjective Mood Scores as a Function of Marijuana Strength and Naltrexone Dose. |
8.0; 25.0; 6.7; 34.0; 8.1; 31.6 | — |
| PRIMARY Change in Mean Psychomotor Task Performance as a Function of Marijuana Strength and Naltrexone Dose |
86.2; 86.1; 86.7; 84.7; 83.4; 83.5 | — |
| PRIMARY Change in Mean Heart Rate as a Function of Marijuana Strength and Naltrexone Dose. |
68.5; 70.7; 65.8; 72.1; 67.3; 72.7 | — |
Eligibility Criteria
Inclusion Criteria
- Current marijuana use
- Able to perform study procedures
- 21-45 years of age
- Women practicing an effective form of birth control
Exclusion Criteria
- Current, repeated illicit drug use (other than marijuana)
- Presence of significant medical illness (e.g., diabetes, cardiovascular disease, hypertension, examination, laboratory hepatitis, clinically significant laboratory abnormalities, tests, 12-lead ECG, Mantoux test LFTs > 3x upper limit of normal)
- History of heart disease
- Request for drug treatment
- Current parole or probation
- Pregnancy or current lactation
- Recent history of significant violent behavior
- Previous adverse reaction to naltrexone
- Major current Axis I psychopathology Psychiatric interview (e.g., major depressive disorder, bipolar disorder, suicide risk, schizophrenia)
- Current use of any prescription or over-the-counter medication
Data sourced from ClinicalTrials.gov (NCT00403117). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.